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Wednesday, September 5, 2012

http://www.thenation.com/blog/169262/medical-research-fraud-professors-go-unpunished-glaxo-3-billion-guilty-plea-over-paxil#The head of the UCLA hospital, Dr. David Feinberg, and twenty-one other academics are going unpunished despite their role in perpetrating a healthcare fraud that has resulted in the largest fine ever paid by a pharmaceutical company in US history.On July 3 GlaxoSmithKline pleaded guilty to criminal charges and agreed pay $3 billion in fines for promoting its bestselling antidepressants for unapproved uses. The heart of the case was an article in a medical journal purporting to document the safety and efficacy of Paxil in treating depression in children. The article listed more that twenty researchers as authors, including UCLA’s Feinberg, but the Department of Justice found that Glaxo had paid for the drafting of the fraudulent article to which the researchers had attached their names.The study, which, according to The Chronicle of Higher Education, had been criticized because it “dangerously misrepresented data” and had “hidden information indicating that the drug promoted suicidal behavior among teenagers,” was published in 2001 in The Journal of the American Academy of Child and Adolescent Psychiatry. The lead “author” was Martin B. Keller, at the time a professor of psychiatry at Brown University. He retired this month. The article had been exposed as fraudulent in a 2007 BBC documentary and in the 2008 book Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass. Glaxo’s guilty plea, according to the Chronicle, included an admission that “the article constituted scientific fraud.”Paxil went on sale in the US in 1993 and, according to Bass, prescriptions for children “soared” after the study appeared, even though research showed Paxil was not more effective than a placebo. But in 2004, theChronicle reports, British regulators warned against prescribing Paxil to children, after a study reported that children taking Paxil were nearly three times more likely to consider or attempt suicide. Then the US FDA issued a similar warning. Paxil sales totaled more than $11 billion between 1997 and 2005.Brown University officials said they had no plans to take action against Keller. At UCLA, Dale Triber Tate, a spokesperson for the medical center and Dr. Feinberg, had no comment. The journal that published the fraudulent research has failed to retract it, and editor-in-chief Andres S. Martin, a professor of psychiatry at Yale, told the Chronicle he had no comment on the options the journal might take.Feinberg and Keller were among twenty-two people listed as “authors” on the fraudulent article. Others included Karen D. Wagner, now professor and vice chair of psychiatry at the University of Texas Medical Branch at Galveston; Boris Birmaher and Neal D. Ryan, professors of psychiatry at the University of Pittsburgh; Graham J. Emslie, professor of psychiatry at the University of Texas Southwestern Medical Center at Dallas; and Michael A. Strober, professor of psychiatry at UCLA.Although Glaxo pled guilty and paid $3 billion in fines, none of the academics have been disciplined by their universities for their roles in perpetrating research fraud. Moreover, according to the Chronicle, several continue to receive federal grants from the National Institute of Health.

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